Auditory brainstem implants: an analysis of adverse events in the MAUDE database.

OBJECTIVE: Auditory Brainstem Implants (ABI) are used to restore hearing in patients lacking appropriate cochlear anatomy and/or cochlear nerve. The objective of this study was to examine the Manufacture and User Facility Device Experience (MAUDE) database to analyze adverse events. STUDY DESIGN: This is a study of a multi-institutional database maintained by the US FDA. SETTING: A database analysis was performed via collaboration of multiple clinicians at tertiary referral centers. METHODS: The MAUDE database was queried for Medical Device Reports (MDRs) relating to ABIs. MDRs were identified using the advanced search term "Implant, Auditory Brainstem" and reviewing all reports with the basic search term "Brainstem Implant". All collected reports were individually reviewed. RESULTS: A total of 265 individual patient reports were reviewed, of which 55 reports met inclusion criteria. Reports regarding audiologic outcome included failure to provide hearing benefit (n = 27), implant failure/device malfunction (n = 10), and device non-use (n = 6). Postoperative complications included local skin infection (n = 3), CSF leak (n = 3), elevated ICP (n = 1), surgical site dehiscence (n = 1), swelling (n = 1), seroma formation requiring drainage (n = 1), and meningitis (n = 2). Two patients had dislodged magnets during 1.5 Tesla MRI acquisition. There were 35 instances of full explantation of the device and 1 partial removal; 13 patients had a new device implanted following explantation. CONCLUSIONS: Poor hearing results, device failure, and non-use were commonly reported causes for explanation in this analysis. This information can aid physicians in counseling patients and family members and managing device expectations.

Otologic use of porcine small intestinal submucosal graft (biodesign): A MAUDE database review.

OBJECTIVE: To review and summarize reported adverse events related to the use of porcine small intestine submucosal grafts (Biodesign™) in otologic procedures. STUDY DESIGN: Retrospective cross-sectional analysis. SETTING: Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database. MATERIAL AND METHODS: The MAUDE database was queried for all medical device reports (MDR) related to otologic use of Biodesign™ (Cook Medical, Bloomington, IN) from January 2016 to November 2022. Adverse events (AEs) were identified by reviewing all reports with the basic search term "Biodesign" and "Biodesign, Otologic". Reports were individually reviewed and categorized with special attention to AEs. RESULTS: A total of 500 reports were reviewed. Since FDA approval of Biodesign™ in 2016, there have been 5 adverse events reported for use of Biodesign™ during otologic surgery (tympanoplasty, n = 3; stapes surgery, n = 2). All reported events described patient injury, and all cases required at least one revision surgery. Four cases described significant foreign body inflammatory reactions. Complications included hearing loss (n = 3), severe otalgia (n = 2), persistent perforation (n = 2), vertigo (n = 2), and facial paralysis (n = 1). CONCLUSION: The use of porcine small intestinal submucosal graft has been thought to be a safe and effective option for otologic surgery, with the advantage of availability without graft harvest in minimally invasive endoscopic surgery. However, foreign body or granulomatous reactions have been documented and should be considered prior to its use in otologic surgery.

Health-care utilization for sinusitis after pneumococcal vaccination in patients with low antibody titers.

BACKGROUND: Pneumococcal antibody deficiency has been the subject of limited study in chronic rhinosinusitis (CRS) and has not been studied in recurrent acute rhinosinusitis (RARS). The 23-valent pneumococcal polysaccharide vaccine (PPSV23) is considered for patients with nonprotective Streptococcus pneumoniae titers. We hypothesized that both RARS and CRS patients with deficient S pneumoniae titers and subsequent PPSV23 vaccination would have reduced health-care encounters for sinusitis and fewer prescriptions for antibiotics or steroids. METHODS: A retrospective cohort study was performed of patient encounters between January 2011 and December 2019. All patients included were ≥18 and ≤65 years old with a diagnosis of CRS or RARS and pneumococcal titer data. Patients with immunodeficiency and comorbid conditions requiring PPSV23 vaccination before 65 years of age were excluded. RESULTS: A total of 938 patients were included in the study. Nonprotective antibody titers were present in 75.8% of CRS and 74.8% of RARS patients. A total of 306 patients with deficient antibody titers received the PPSV23 vaccine. Eighty-nine percent of CRS and 90.1% of RARS patients had protective responses. Among the 217 patients with continuous data from 2 years before through 2 years after PPSV23 vaccination, a decrease in the number of encounter diagnoses of CRS (p < 0.0001) and RARS (p = 0.0006) was observed. Decreases in the frequency of antibiotic (p = 0.002) and corticosteroid (p = 0.04) prescriptions were also appreciated. CONCLUSION: Most patients with CRS and RARS have nonprotective antibody titers. PPSV23 administration significantly decreases health-care utilization.

Intranasal Azelastine and Fluticasone as Combination Therapy for Allergic Rhinitis: Systematic Review and Meta-analysis.

OBJECTIVE: Combination therapy with intranasal azelastine and fluticasone propionate is an option for treatment of allergic rhinitis. This systematic review and meta-analysis examines existing literature to determine efficacy in treating allergic rhinitis compared to monotherapy. DATA SOURCES: The PubMed, EMBASE, Cochrane, and MEDLINE databases were systematically searched for randomized controlled trials using AzeFlu nasal spray. REVIEW METHODS: Randomized, controlled trials that reported symptom relief of allergic rhinitis in males and females of all ages were included. Results were reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) standard. RESULTS: Systematic review identified 8 articles suitable for review. The risk of bias was generally low. All studies exhibited a greater decrease in patient-reported symptom scores in patients treated with combination therapy compared to monotherapy or placebo. Meta-analysis revealed superiority of combination therapy in reducing Total Nasal Symptom Score compared to placebo (mean change from baseline: -2.41; 95% confidence interval [CI], -2.82 to -1.99; P < .001; I2 = 60%), azelastine (mean change from baseline: -1.40; 95% CI, -1.82 to -0.98; P < .001; I2 = 0%), and fluticasone (mean change from baseline: -0.74; 95% CI, -1.17 to -0.31; P < .001; I2 = 12%). CONCLUSION: Current evidence supports both efficacy and superiority of combination intranasal azelastine and fluticasone in reducing patient-reported symptom scores in patients with allergic rhinitis. Combination nasal spray should be considered as second-line therapy in patients with allergic rhinitis that is not controlled with monotherapy.

Adenotonsillectomy for Obstructive Sleep Apnea and Quality of Life: Systematic Review and Meta-analysis.

Objective To determine the impact of adenotonsillectomy on the quality of life of pediatric patients with obstructive sleep apnea (OSA) and to identify gaps in the current research. Data Sources The MEDLINE, EMBASE, and Cochrane databases were systematically searched via the Ovid portal on June 18, 2016, for English-language articles. Review Methods Full-text articles were selected that studied boys and girls <18 years of age who underwent adenotonsillectomy for OSA or sleep-disordered breathing and that recorded validated, quantitative quality-of-life outcomes. Studies that lacked such measures, performed adenotonsillectomy for indications other than OSA or sleep-disordered breathing, or grouped adenotonsillectomy with other procedures were excluded. Results Of the 328 articles initially identified, 37 were included for qualitative analysis. The level of evidence was generally low. All studies involving short-term follow-up (≤6 months) showed improvement in quality-of-life scores after adenotonsillectomy as compared with preoperative values. Studies involving long-term follow-up (>6 months) showed mixed results. Modifications to and concurrent procedures with conventional adenotonsillectomy were also identified that showed quality-of-life improvements. Three studies were identified for meta-analysis that compared pre- and postoperative Obstructive Sleep Apnea-18 scores. Short- and long-term follow-up versus preoperative scores showed significant improvement ( P < .001). Short- and long-term scores showed no significant difference. Conclusion This systematic review and meta-analysis demonstrate adenotonsillectomy's effectiveness in improving the quality of life of pediatric patients with OSA. This is well demonstrated in the short term and has strong indications in the long term.

Eagle Syndrome Secondary to Osteoradionecrosis of the Styloid Process.

BACKGROUND: Eagle syndrome is a rare condition caused by elongation of the styloid process or ossification of the stylohyoid ligament. The symptomatology can be vague but may include dysphagia, odynophagia, otalgia, foreign body sensation, facial pain, trismus, headache, tinnitus, increased salivation, and/or voice changes. CASE REPORT: We present the case of a 58-year-old male believed to have acquired Eagle syndrome secondary to osteoradionecrosis of the styloid process following radiation therapy used as adjuvant treatment for a surgically resected pT2N1M0 squamous cell carcinoma of the right tonsil. CONCLUSION: Radiation is a common component of treatment for head and neck cancers. The diagnosis of Eagle syndrome secondary to osteoradionecrosis of the styloid process is an elusive, but important, diagnosis to consider because the condition can be treated successfully.